Aprea announces positive data from a clinical Phase I/II study with APR-246 in patients with advanced cancers
STOCKHOLM – September 18, 2012. Aprea today announced positive data from a completed Phase I/II clinical study with its investigational drug APR-246. The results from the study have been published in the Journal of Clinical Oncology. Based on the positive data, Aprea is planning to advance APR-246 into a Phase II proof-of-concept study in ovarian cancer. Aprea is a Karolinska Development portfolio company.
In the Phase I/II-trial, escalating doses of APR-246 were
administered as monotherapy to 22 patients with advanced blood- or
prostate cancer during up to four consecutive days. Dose limiting
toxicity was shown at plasma levels well above predicted
therapeutic plasma levels. The study also demonstrated
dose-proportional and time-independent pharmacokinetics for APR-246
over the dose range studied.
The results from the study have been published in the Journal of
Clinical Oncology. In addition to reporting that the drug was well
tolerated, the authors conclude from the study that APR-246 induces
biological effects and that there are cases of clinical effects on
tumor burden. One patient with advanced blood cancer demonstrated a
50 percent reduction in the number of blast cells in the bone
marrow.
Ulf Björklund, CEO, Aprea:
“These are very encouraging study results. We are now
planning to take the p53-activating compound APR-246 forward into a
Phase II-trial in epithelial ovarian cancer with mutated p53 in
combination with conventional chemotherapy.”
In the new proof-of-concept study, APR-246 will be administered in
combination with the reintroduction of a carboplatin-based regimen.
A striking synergistic effect between APR-246 and the very active
and frequently used cancer product carboplatin has been observed in
pre-clinical experiments.
Torbjörn Bjerke, CEO, Karolinska Development:
“This is indeed promising data. Although it was primarily a
safety trial, the data indicates that APR-246 has an anti-tumor
effect. APR-246 was well tolerated and, importantly, the safety
profile is different from traditional cytostatic drugs. With these
new results we can see a clear path forward for APR-246, especially
in carboplatin-resistant patients.”
For further information, please contact:
Ulf Björklund, CEO, Aprea AB
Phone: +46 (0)8 508 845 04, e-mail: ulf.bjorklund@aprea.com
Torbjörn Bjerke, CEO, Karolinska Development AB
Phone: +46 (0)72 744 41 23, e-mail:
torbjorn.bjerke@karolinskadevelopment.com
TO THE EDITORS
About Aprea
Aprea AB is a Swedish biotech company focusing on discovery and
development of novel anticancer compounds targeting the tumor
suppressor protein p53. Aberrations in p53 are common in many
various cancer forms and are associated with increased resistance
to standard chemotherapy and thus poor prognosis. Aprea is a
Karolinska Development AB (publ) portfolio company. The other main
owners are Östersjöstiftelsen, Praktikerinvest and KCIF
Co-Investment Fund KB. For more information, please visit
www.aprea.com .
About Karolinska Development AB
Karolinska Development aims to create value for investors,
patients, and researchers by developing innovations from world
class science into products that can be sold or out-licensed with
high returns. The business model is to: SELECT the most
commercially attractive medical innovations; DEVELOP innovations to
the stage where the greatest return on investment can be achieved;
and COMMERCIALIZE the innovations through the sale of companies or
out-licensing of products. An exclusive deal flow agreement with
Karolinska Institutet Innovations AB, along with other cooperation
agreements with leading Nordic universities, delivers a continuous
flow of innovations. Today, the portfolio consists of 35 projects,
of which 15 are in clinical development. For more information,
please visit www.karolinskadevelopment.com.
Karolinska Development is listed on NASDAQ OMX. Karolinska
Development may be required to disclose the information provided
herein pursuant to the Securities Markets Act.
Posted: September 2012
